There are many clinical problems or needs which may be treated through procedures to create permanent occlusion of body lumens. Some examples of these are the occlusion of fallopian tubes to sterilize a female patient, occlusion of the vasa deferentia for sterilization of a male patient, the occlusion of varicose veins, occlusion of arteries feeding regions of cancerous tumors, occlusion of the bile ducts, or the occlusion of arteries in the neuro-vasculature to isolate aneurysms.
In the case of female sterilization, there are many different approaches by which this procedure can be performed. These include: full surgical procedures, small incision surgical procedures, and trans-cervical approaches. The specific method of creating the occlusion can also vary. In surgical approaches, the fallopian tubes can be occluded by applying a clip or suture to pinch the tubes closed or by using energy application to seal the tubes closed. These approaches tend to be acutely effective but also require the invasiveness and consequent recovery of surgical procedures.
In trans-cervical approaches for female sterilization, multiple technologies have been developed in the last 10-15 years which utilize implants in the fallopian tubes delivered through scopes and catheters via the cervix and uterus. These implants act in different ways including energy delivery, inflammatory materials to provoke a healing response, and physical plugging. An example of a plugging approach is shown in U.S. Pat. No. 3,805,767. Pure mechanical plugging approaches have not been well accepted to date due to a relatively high rate of ejection of the plugs by the body. Other implants have relied upon a proliferative response of the body to the implant. These techniques may rely on this body response to both anchor the implant permanently and to complete the occlusion of the fallopian tube. Examples of this approach are described in a family of patents to Nikolchev et al. including U.S. Pat. Nos. 6,176,240, 6,634,361, 6,679,266, 6,684,884 and 6,705,323. U.S. Pat. No. 7,073,504 also discloses an approach for use in either the fallopian tubes or the vasa deferentia for implanting a device having an open structure which enables tissue ingrowth to complete the occlusion of the lumen.
All of the trans-cervical technologies which have been introduced to date which have shown good enough effectiveness and reliability to achieve common use have had a common limitation. This is that they require a healing response to the implant to yield a reliable occlusion of the fallopian tube. Consequently they also often require follow up assessment after some period of time to allow the healing response to progress to a degree to assure that the procedure has been effective. This can present reliability issues because it requires the patient to use another form of birth control in the interim period before the occlusion has been verified. It also is inconvenient for the patient and more expensive with the need for the follow up assessment.
U.S. Pat. No. 6,896,682 does disclose an apparatus which is intended to create an acute occlusion with the application of an o-ring over an inverted segment of the fallopian tube via a transcervical approach. This approach is still clinically unproven at this time.
For these reasons and others there is a need for a new method and apparatus which enables reliable occlusion of body lumens through a non-surgical approach which is both effective more quickly or acutely and is permanent.